FDA Clears Merck's Januvia

The drug is a once-daily treatment for type 2 diabetes.
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Updated from 9:36 a.m. EDT

Merck

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said Tuesday it has received U.S. approval to begin selling Januvia, a new type of diabetes drug that's more versatile than existing blood-sugar control medications.

The Food and Drug Administration approved Januvia, a once-a-day tablet, as a single therapy or in combination with two different types of diabetes pills.

Many analysts view Januvia as the foundation for a Merck turnaround, as well as the next big thing in diabetes care. Januvia belongs to a new class of drugs called called dipeptidyl peptidase-4 inhibitors, or DPP-4 inhibitors.

The potential benefit for DDP-4 drugs is that they address blood-sugar control in two ways -- acting on cells in the pancreas that stimulate the production of insulin and affecting other cells in the pancreas that signal the liver to reduce the production of sugar. Insulin is the protein hormone that helps convert sugar into energy.

DPP-4 inhibitors are designed to treat type 2 diabetes, which accounts for most cases of the disease. With type 2 diabetes, the body doesn't make enough insulin or cells fail to respond to the insulin. Januvia won't work for type 1 diabetes, in which the body isn't able to produce insulin.

Merck is also seeking FDA approval for a combination pill that contains Januvia and the generic blood-sugar control medication metformin. The FDA could rule on the drug, called MK-0431A, by March. Merck is trying to get regulatory clearance in foreign markets for both Januvia and the combination pill.

The dual action of DPP-4 drugs and the fact that they are being developed as once-a-day pills has spawned numerous research efforts. Among the companies with similar products, the closest to Merck is

Novartis

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, whose Galvus is being reviewed by the FDA. The agency could make a decision by the end of the year.

Other drugmakers developing DPP-4 inhibitors include

Bristol-Myers Squibb

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, Japan's

Takeda Pharmaceuticals

, Britain's

GlaxoSmithKline

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, France's

Sanofi-Aventis

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and the U.S. biotech

OSI Pharmaceuticals

(OSIP)

.

The big contest is between Merck and Novartis, because first-to-market medications in new drug categories often have an advantage over competitors. Both companies have been testing their DPP-4 compounds against other diabetes drugs

, trying to show that the new medications offer more benefits. Januvia and Galvus haven't been tested against each other.

Merck said clinical trials show that Januvia isn't linked to weight gain or hypoglycemia, a drop in blood sugar. These side effects are associated with some diabetes medications. Merck added that clinical trials show "an overall incidence of side effects comparable to placebo." The most common side effects were stuffy or runny nose and sore throat, upper respiratory infection and headaches.

Almost 21 million people in the U.S. have diabetes, with type 2 representing more than 90% of the cases, Merck says. As an indication that Wall Street had expected Januvia's approval by the FDA, Merck's stock was off 28 cents to $43.48 by midday.